Genmab — Oktober 2014

[investor1989]

Dog irriterende hvis de starter forfra. Det gamle studie havde jo rekrutteret i over 12 måneder

[Solsen]

Jeg er ike oberasket over at de går ned i dosis. Dog at de går ned i 20 mg er mindre end jeg havde forventet. Men ingen tvivl om at det er vel overvejet, idet rrms forsøgene bliver meget store og dermed dyre.

[Solsen]

Ikke overrasket...

[Sukkeralf]

Det er stadig 20 mg hver fjerde uge kontra 60 mg hver 12 uge - det giver samme mængde, så umiddelbart skulle man tro det var for at minske bivirkninger eller måske en lavere men hyppigere dosis giver samme resultat

[Sukkeralf]

Eller måske endda bedre effekt

[Solsen]

Ja det er balancen mellem at holde b-lymfocytterne nede og der er tilstrækkelige til at immunforsvaret er aktivt

[Solsen]

Vi har fundet en amalyse af det forhold tidligere veæ at mærke med ofatumumab behandling.

[Solsen]

Analyse og vel at mærke ....

[Sukkeralf]

MadsSkjern i det gamle studier står der:

[Sukkeralf]

Time to sustained remission on minimal steroid therapy [ Time Frame: Up to 60 weeks ] [ Designated as safety issue: No ]
Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintained a dose <=10 mg/day with no new or nonhealing (established) lesions for >=8 weeks and maintained the status until Week 60 will be assessed

[Sukkeralf]

Så der bruges også steroid i dette

[Solsen]

MIRROR: Threshold Identified for Ofatumumab Therapy in MS

Results of the phase 2 study suggest that an optimal dose can be found that will give maximal suppression of MS lesions without completely eradicating all B cells.

Medscape (www.medscape.com)

[Sukkeralf]

Uanset hvad betyder det vel ikke så meget, for det er en lille indikation og royalty i de autoimmune sygdomme er kun 10%. Men så længe Arzerra ikke omsætter for mere, så kan vi bruge al omsætning

[Solsen]

Ja skidt med den indikation....bortset synd for pts.

[Sukkeralf]

Hvad står der i dit link - har ikke adgang

[Solsen]

Presenting the new analysis at the American Academy of Neurology (AAN) 66th Annual Meeting, Daren Austin, PhD, from GSK UK, explained that the study included a large range of doses in an attempt to pinpoint the lowest dose for significantly reducing MRI lesion activity.

[Solsen]

Forstår ikke du ikke har adgang - Medscape...

[Solsen]

For the MIRROR study, 231 patients with relapsing-remitting MS were randomly assigned to 1 of 4 doses of ofatumumab or placebo. The 4 doses were 3 mg every 12 weeks, 30 mg every 12 weeks, 60 mg every 12 weeks, and 60 mg every 4 weeks. After 12 weeks, the placebo group received 3 mg of ofatumumab. The study treatments were given for 24 weeks. The primary endpoint was suppression of MRI lesion activity during the first 12 weeks.

Results suggested a 90% or greater reduction in the cumulative numbe

[Solsen]

Results suggested a 90% or greater reduction in the cumulative number of new T1 gadolinium-enhancing lesions for all cumulative doses of ofatumumab 30 mg or greater during weeks 4 to 12.

[Solsen]

Det kan jo være yderligere data og dosisforsøg har påvist at 10 mg er nok.